NCT01531647已完成1 期
A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir When Given With Raltegravir in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Effect of steady-state ritonavir-boosted danoprevir on steady-state raltegravir pharmacokinetics: Area under the concentration-time curve (AUC)
研究概览
简要总结
This open-label, multiple dose, single sequence crossover study will evaluate the drug-drug interaction between danoprevir/low-dose ritonavir and raltegravir in healthy volunteers. Subjects will receive raltegravir on Days 1-4 and, after a washout period of 3 days, danoprevir and low-dose ritonavir on Days 8-21, in combination with raltegravir on Days 18-21.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smoking male and female adults, 18 - 55 years of age, inclusive
- •Healthy status defined by absence of evidence of any active or chronic disease
- •Medical history without major, recent, or ongoing pathology
- •Weight >/= 50.0 kg
- •Body mass index (BMI) 18.0 - 32-0 kg/m2
- •Willingness to abstain from alcohol, xanthine-containing beverages or food (e.g. coffee, tea, cola, chocolate, "energy drinks") from 48 hours prior to entry in the clinical site until discharge
- •Females of child-bearing potential and males and their female partners of child-bearing potential must agree to use 2 forms of contraception, one of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom and diaphragm; acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device (IUD) and/or spermicide
排除标准
- •Pregnant or lactating females or males with female partners who are pregnant or lactating
- •Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
- •Positive test for drugs of abuse at screening or prior to admission to the clinical site during any study period
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
- •Use of hormonal contraceptives within 30 days before the first dose of study medication
- •History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
研究组 & 干预措施
Period 1 Control
Active Comparator
干预措施: raltegravir (Drug)
Period 2 danoprevir/ritonavir
Experimental
干预措施: danoprevir (Drug)
Period 2 danoprevir/ritonavir
Experimental
干预措施: raltegravir (Drug)
Period 2 danoprevir/ritonavir
Experimental
干预措施: ritonavir (Drug)
结局指标
主要结局
Effect of steady-state ritonavir-boosted danoprevir on steady-state raltegravir pharmacokinetics: Area under the concentration-time curve (AUC)
时间窗: approximately 2 months
次要结局
- Effect of steady-state raltegravir on danoprevir/ritonavir pharmacokinetics: Area under the concentration-time curve (AUC)(Pre-dose Days 8. 14, 15, 16 and 20, pre-and up to 24 h post-dose Days 17 and 21)
- Safety: Incidence of adverse events(approximately 2 months)
研究者
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